Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

US FDA Strategy On Abuse-Deterrent Opioids Needs Rethinking, Panelists Say

Executive Summary

Deterring intravenous abuse over other routes of abuse should be agency's priority, some advisory committee members say during discussion of abuse patterns and risks with Endo’s reformulated Opana ER.

You may also be interested in...



‘Abuse-Deterrent’ Opioids May Be Headed For A Terminology Change

US FDA will survey health care providers’ current understanding of analgesic abuse-deterrent formulations and conduct an experimental study exploring the effectiveness of different terminology and descriptions for such products; agency has heard complaints from its own AdComms about terminology around abuse deterrence.

Opioids: Intellipharmaceutics' Pursuit Of IV-Only Deterrence Claim May Backfire

US FDA advisory committee may not be comfortable with intravenous abuse-deterrence labeling for Rexista (oxycodone extended-release) when the sponsor has not assessed the impact on other routes of abuse purportedly targeted by the formulation.

Postmarketing Studies On Abuse-Deterrent Opioids Could Get New Look

Data sources and methodologies to evaluate real-world effects of abuse-deterrent formulations will be focus of US FDA public meeting in July; value and feasibility of assessing the public health effects of such products more broadly is up for discussion.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID1132298

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel